Antimicrobial Stewardship Effects of Interpretive Comments for Faecal PCR Tests
Bacterial gastroenteritis is a common condition seen in Aotearoa New Zealand, which is typically diagnosed by PCR testing on a stool sample. Most causes of bacterial gastroenteritis (e.g. Campylobacter spp, Salmonella spp, Yersinia spp) cause a self-limiting illness and antibiotic therapy is not required. Indeed, guidelines available for community healthcare providers in Aotearoa (e.g. Community HealthPathways, recently released national antimicrobial guidelines Te Whata Kura) recommend against antibiotic therapy for the vast majority of cases.
A recent internal analysis at Awanui Laboratories of community faecal pathogen PCR testing revealed that antibiotic prescribing was very common after a positive result (ranging between 20-40% for the various individual pathogens), which suggests many community healthcare providers may not be following the recommended approach for the management of these infections. Given how common infectious gastroenteritis is in Aotearoa, and the volume of tests performed (approximately 100,000 through the Awanui network per year), this prescribing behaviour may represent a large volume of unnecessary antibiotic use in our communities, with resultant potential harmful effects at the individual patient level and population level via side effects, disruption to the faecal microbiome, and impacts on antimicrobial resistance (AMR).
In previous work we have demonstrated that interpretive comments, when added to laboratory reports, can have a significant positive effect on prescriber behaviour (https://doi.org/10.1093/jac/dkad384), but this has not been examined in relation to faecal pathogen testing.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This is a cluster randomised crossover trial, where four laboratories within the Awanui Labs network in Aotearoa New Zealand will act as the clusters. Each laboratory will be assigned four intervention levels, which will be implemented in random order over the course of the 12 month study period (i.e. 3 months per intervention).
The intervention will consist of interpretive comments that are appended to laboratory reports where a stool sample has been submitted for faecal bacterial pathogen detection (predominantly tested via multiplex PCR methodology) and one of the target organisms has been detected. The target organisms are Campylobacter spp, Shigella spp/Entero-invasive Escherichia coli, Salmonella spp, Yersinia spp, and Aeromonas spp.
There will be four different intervention levels: 1. a comment that reminds requesters that most acute bacterial gastroenteritis does not require antibiotic treatment, as per local guidelines; 2. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic over use at the population level (i.e. AMR); 3. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic overuse at the individual patient level e.g. harms due to side effects; 4. is a the control group, where no comment is appended.
The four levels will be auto added by each lab, each for a three month period, in the random order allocated at the beginning of the study.
Outcome measures will relate to antibiotic use in the time period following the laboratory report, plus unplanned hospitalisation out to 30 days post report.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Max Bloomfield, MBChB
- Número de telefone: +64272089584
- E-mail: maxim.bloomfield@ccdhb.org.nz
Locais de estudo
-
-
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Auckland, Nova Zelândia
- Recrutamento
- Awanui Labs Auckland
-
Contato:
- Max Bloomfield, MBChB
- Número de telefone: 0272089584
- E-mail: maxim.bloomfield@ccdhb.org.nz
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Christchurch, Nova Zelândia
- Recrutamento
- Awanui Labs Christchurch
-
Contato:
- Max Bloomfield, MBChB
- Número de telefone: 0272089584
- E-mail: maxim.bloomfield@ccdhb.org.nz
-
Dunedin, Nova Zelândia
- Recrutamento
- Awanui Labs Dunedin
-
Contato:
- Max Bloomfield, MBChB
- Número de telefone: 0272089584
- E-mail: maxim.bloomfield@ccdhb.org.nz
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Wellington, Nova Zelândia, 6012
- Recrutamento
- Awanui Labs Wellington
-
Contato:
- Max Bloomfield, MBChB
- Número de telefone: 0272089584
- E-mail: maxim.bloomfield@ccdhb.org.nz
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age over six months
- Stool sample submitted to Awanui Labs for faecal bacterial pathogen testing from a community health provider during the study period
- Test results report the detection of: Campylobacter spp, Shigella spp/Entero-invasive Escherichia coli, Salmonella spp, Yersinia spp, or Aeromonas spp.
Exclusion Criteria:
- Samples where only Clostridioides difficile or Helicobacter pylori testing has been requested will be excluded
- Samples sent for Public Health testing (e.g. testing for clearance of Salmonella spp) will be excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Interpretive laboratory comment - guideline
Interpretive comment with advice to follow local guidelines
|
Interpretive commend added to laboratory report - contents of comment will depend on associated arm
|
|
Comparador Ativo: Interpretive laboratory comment - guideline + population harms
Interpretive comment with advice to follow local guidelines PLUS comment about population level harms of antibiotic overuse (i.e.
AMR)
|
Interpretive commend added to laboratory report - contents of comment will depend on associated arm
|
|
Comparador Ativo: Interpretive laboratory comment - guideline + individual harms
Interpretive comment with advice to follow local guidelines PLUS comment about individual patient harms of antibiotic overuse (e.g.
side effects)
|
Interpretive commend added to laboratory report - contents of comment will depend on associated arm
|
|
Sem intervenção: Control
No comment added to lab report
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Specific antibacterial dispensing
Prazo: Within 5 days of lab report
|
Antibacterial dispensing within 5 days of laboratory report for agents that are more specific for the treatment of bacterial gastroenteritis: amoxicillin, azithromycin, ciprofloxacin, doxycycline, erythromycin, co-trimoxazole
|
Within 5 days of lab report
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Any antibacterial dispensing
Prazo: Within 5 days of lab report
|
Antimicrobial dispensing within 5 days of laboratory report for any antibacterial agent
|
Within 5 days of lab report
|
|
Antibacterial dispensing within 30 days
Prazo: Within 30 days of lab report
|
Antimicrobial dispensing within 30 days of laboratory report
|
Within 30 days of lab report
|
|
Unplanned hospital admission
Prazo: Within 5 and 30 days of lab report.
|
Unplanned hospital admission within 5 and 30 days of laboratory report
|
Within 5 and 30 days of lab report.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- FPC2026
Plano para dados de participantes individuais (IPD)
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